Molecular Diagnostics Program in Prostate Cancer

Key Clinical Collaboration with Dana-Farber Cancer Institute

Since August 2006, Source MDx and the Dana-Farber Cancer Institute (DFCI) have been collaborating on the development of a series of prognostic, predictive and early detection molecular diagnostic tests for prostate cancer based on Source MDx's patented Precision Profile™ technology. At the 2009 Annual ASCO Meeting in May, DFCI oncologists presented successful clinical validation results of Source MDx's six-gene Precision Profile for Early Detection of Prostate Cancer that is used in conjunction with the PSA test to improve the early diagnosis of prostate cancer over the use of PSA alone. In February 2009, DFCI and Source MDx announced that another Source MDx diagnostic test predicted survival in men with castration-resistant prostate cancer.

Source MDx's patented diagnostic tests are based on RNA transcript-based gene expression measurements in whole blood using quantitative PCR, optimized for clinical use in a commercial setting. These diagnostic tests that have been validated at the DFCI have the potential to improve patient outcomes and dramatically reduce current costs to the healthcare system through the practice of evidence-based medicine.

Click here to view our prostate cancer early detection presentation at ASCO May 2009

Click here to view our prostate cancer early detection poster at ASCO May 2009

Click here to view our prostate cancer prognostic poster at ASCO GU Symposium February 2009

Dana-Farber Prostate Cancer Team

The DFCI prostate cancer science and clinical team is led by:

• Dr. Myles Brown, Chief, Division of Molecular and Cellular Oncology
• Dr. Philip Kantoff, Chief Clinical Research Officer and Chief of the Division of Solid Tumor Oncology at Dana-Farber
  Dr. Kantoff is also the leader of the Dana-Farber/Harvard Cancer Center Prostate Cancer Program, and Director of the prostate cancer Specialized Program of Research Excellence (SPORE).
• Dr. William K. Oh, Clinical Director, Lank Center for Genitourinary Oncology
• Dr. Robert W. Ross, Attending Physician, Lank Center for Genitourinary Oncology

Next Steps for Source MDx/Dana-Farber Prostate Cancer Collaboration

Source MDx is initiating the Prostate Cancer Individual Molecular Signature Evaluation (PReCISE) Trial, under the leadership of Dr. William Oh and Dr. Philip Kantoff. The PReCISE trial plans to enroll 1,000 patients at ten participating clinical institutions and will include two phases. The first phase will enlist 400 patients to further evaluate the commercial feasibility of the Precision Profile diagnostic test for early detection of prostate cancer. The second phase, designed as a pivotal trial, will enlist 600 patients to validate the sensitivity and specificity of the diagnostic test.

The Prostate Cancer Clinical Trials Consortium (PCCTC) is initiating a prospective, multi-site validation trial and will be using Source MDx's six-gene Precision Profile for Prostate Cancer Prognosis to stratify aggressive vs. non-aggressive castrate-resistant prostate cancer patients. The PCCTC is a national clinical research group comprised of thirteen top U.S. research institutions including Memorial Sloan-Kettering Cancer Center and DFCI.

Source MDx and DFCI are moving forward with additional prospective multi-site clinical trials in order to make this family of prostate cancer tests available to physicians and patients at the Dana-Farber/Harvard Cancer Center affiliated hospitals (DF/HCC). With continued validation of these tests, Source MDX anticipates further demonstration of improved patient outcomes and reduced health care costs leading to commercial viability.